“BLIND-SPOTS” OF MEDICINE LIFE-CYCLE FROM THE POINT OF VIEW OF THE GOOD PRACTICES

Manufacturing, Marketing Pharmaceutical development MEDICINE LIFECYCLE Discovery ? GCP Phase I Preclinical studies Preclinical studies Clinical studies Approval Phase IV GLP Manufacturing, Marketing Post-approval studies GMP Phase II Animal welfare ? Phase III ? Pharmaceutical development ?

GOOD PRACTICE IN FUNDAMENTAL STUDIES ≈20% of all preclinical studies in Russia HANDBOOK ON QUALITY PRACTICES IN BASIC BIOMEDICAL RESEARCH (QPBR) in vitro, in silico screening Search for mechanisms of action Pharmacological properties in vitro/in vivo Pharmacokinetics ADME TOX Prior toxicity studies Validation equipment Study director Controls Quality Assurance GLP-like Study plans preparation SOP Reporting documentation

Pre(“Non”)clinical stydies ARE POST-APPROVAL STUDIES GLP or NON-GLP? ≈70% of all preclinical studies in Russia Changing composition of excipients Changing manufacturing facility API New efficient reception Changing course of use Establishing/evidence of the mechanism of action Clarification of toxic properties Adding the usage at pregnancy into instruction BIOSIMILARS GENERICS Pre(“Non”)clinical stydies HYBRID MEDICINES

LABORATORY ANIMALS Good animal welfare practice? Animal environment Methods of euthanasia Animal housing Humanity of manipulations Feeding and watering RUS-LASA Animal number used in study Enrichment of living environment https://www.ufaw.org.uk Pain and stress

PHARMACEUTICAL DEVELOPMENT Medicine compounds Pharmaceutical dosage form Manufacturing Packaging materials Choice of API (concentration, physical state and size of counts) Choice of pharmaceutical dosage form Technological methods Choice of material types, size and package Choice of excipients Functional properties of a pharmaceutical dosage form Functional properties of a commercial product Establishing product expiration date into package Solvents Basis Shells Preservatives Release modifiers Parameters of (PHARMACOPOEIA) Biological activity Stability Sterility and etc. Abnormal toxicity GMP ISO 17025 GLP

Quality Management Systems QUALITY MANAGEMENT SYSTEMS COOPERATING ISO 9001 Process-oriented Quality Management GXP Product-oriented Quality Management GCP GLP GMP GSP ISO 17025 Quality Management Systems ISO 9001

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